IP/C/84  
 
14 November  2019 
(19-7784) Page: 1/9 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
 ANNUAL REVIEW OF THE  SPECIAL COMPULSORY LICENSING SYSTEM  
REPORT TO THE GENERA L COUNCIL  
1.  Paragraph 7 of the Annex to the TRIPS Agreement as amended by the Protocol Amending 
the TRIPS Agreement ( "the Protocol ")1 and p aragraph 8 of the Decision on the Implementation of 
Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of 30 August 2003 
("the 2003 Decision ") respectively2 provide that the Council for TRIPS shall review annually 
the functioning of the Special Com pulsory Licensing System ( "the System ")3 established under 
Article 31 bis of the amended TRIPS Agreement and the 2003 Decision with a view to ensuring its 
effective operation. The Council shall annually report on its operation to the General  Council.  
2.  The Co uncil for TRIPS undertook the fifteenth annual review in November 2018. The 
General  Council took note of the report of the Council for TRIPS (IP/C/82) at its meeting on 
12 December 2018 (WT/GC/M/175, paragraph 8.7).  
3.  The present report covers the period fro m October  2018. At its meeting of 17 -18 October  2019, 
the Council undertook the sixteenth annual review. Annex  1 and Appendix  1 to this report record 
the review and the statements made by delegations.  
4.  Sections 1 and 2 below set out factual information on t he implementation and use of the  System, 
as well as the entry into force of the Amendment to the TRIPS Agreement and the  status of 
acceptances of the Protocol. Section 3 covers resources to support the review of the functioning of 
the System and provides a n overview of capacity building activities organized by the Secretariat in 
response to requests by Members to assist them in making the System work effectively in practice.  
1  INFORMATION ON IMPLE MENTATION AND USE OF  THE SYSTEM ESTABLIS HED UNDER 
THE DECISION  
5.  Since the last annual review, Samoa has notified to the Council for TRIPS its Intellectual Property 
Act 2011 which implements the System into domestic law and permits its use for import.4 An 
overview of all notified implementing laws and regulations, inclu ding hyperlinks to the legal texts, is 
available on a  dedicated page on the WTO website.5 
6.  During the period covered by the present report, no notifications by importing or exporting 
Members pursuant to paragraphs 1(b), 2(a) and 2(c) of the Annex to the ame nded TRIPS  Agreement 
and the 2003 Decision respectively have been made to the Council for TRIPS. The Secretariat 
 
1 The Protocol which was adopted on 6 December 2005 (document WT/L/641) entered into force on 
23 January  2017 (see below under Section 2).  
2 Note that the TRIPS Agreement as amended on 23 January 2017 only applies to WTO Members who 
have accepted the Protoc ol. For other Members who are yet to accept it, the General Council Decision of 
30 August 2003 (document WT/L/540 and Corr.1) continues to constitute the legal basis, including as regards 
the Annual Review of the Special Compulsory Licensing System.  For th e purposes of the 2003 Decision, this 
review is deemed to fulfil the review requirements of Article  IX:4 of the WTO Agreement.  
3 See also the definition in paragraph 1 (b) of the Annex to the amended TRIPS Agreement.  
4 See document IP/N/1/WSM/I/1.  
5 http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm  IP/C/84  
 
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  regularly updates a page on the WTO website to ensure the public availability of notifications made 
under the System.6  
7.  Members seeking to use the System are encouraged to submit their notifications using the 
e-TRIPS Submission System,7 which is an online tool for WTO Members to submit notifications, 
review materials and reports related to the TRIPS Agreement. Access credentials to use the e -TRIPS 
Submission System are available upon request to e-TRIPS@wto.org . In support of an alternative 
way of submitting notifications, a Guide to notifications, including a set of model notifications, is also 
available on the WTO 's webpage.8  The accessibility of notifications, once filed, has been further 
enhanced through their inclusion on the related e -TRIPS Gateway, currently undergoing beta testing 
by Members ' delegates.9 
2  AMENDMENT TO THE TRI PS AGREEMENT  
8.  In accordance with paragraph 3 of Article X of the WTO Agreement, the Protocol entered into 
force on  23 January 2017, by which date two thirds of the WTO Members had accepted it.  
9.  Pursuant to paragraph 3 of Article X of the WTO Agreement, the Protocol takes effect for each 
other Member upon its acceptance. Since the fifteenth annual review in 2018, Georgia and Cuba 
have accepted the Protocol.  
10.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly update d by the WTO Secretariat.10 
11.  As of 1 September 2019, the amended TRIPS Agreement applied to 128 Members. The following 
36 WTO Members were yet to accept the Protocol and continued to operate on the basis of the 2003 
Decision:  
1. Afghanistan  
2. Angola  
3. Antigua & Barbuda  
4. Armenia  
5. Barbados  
6. Burundi  
7. Cabo Verde  
8. Cameroon  
9. Chad 
10. Democratic Republic of the Congo  
11. Djibouti  
12. Ecuador  
13. Eswatini  
14. The Gambia  
15. Ghana  
16. Guatemala  
17. Guinea -Bissau  
18. Guyana  
 
6 http://www.wto.org/english/tratop_e/trips_e/pu blic_health_e.htm  
7 https://www.wto.org/english/tratop_e/trips_e/etrips_e.htm   
8 https://www.wto.o rg/english/tratop_e/trips_e/par6_modelnotifs_e.htm .  
9 Accessible at http://tripsims.wto.org/En/TypesOfDocuments/Paragraph6System . 
10 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm .  IP/C/84  
 
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  19. Haiti 
20. Jamaica  
21. Kazakhstan  
22. Kuwait, the State of  
23. Liberia  
24. Maldives  
25. Mauritania  
26. Mozambi que 
27. Namibia  
28. Niger  
29. Solomon Islands  
30. Suriname  
31. Tonga  
32. Tunisia  
33. Vanuatu  
34. Venezuela, Bolivarian Republic of  
35. Yemen  
36. Zimbabwe  
12.  At the Council 's meetings in November 2018, February 2019 and June 2019, the  respective 
Chairs of the Council for TRIPS updated Members on the state of play of acceptances. They also 
encouraged delegations that were yet to accept the  TRIPS amendment to take the necessary steps 
so that the domestic procedures could be completed as soon as possible. In addition, the 
TRIPS  Council Chair, by mean s of a letter of 10 September 2019, invited Members concerned to 
proceed with the acceptance of the Protocol as this represented a significant contribution to further 
strengthening the legal foundation for the effective exercise of this additional public h ealth flexibility 
in the TRIPS Agreement.  
13.  The Protocol is currently open for acceptance by these Members until 31 December 2019 or 
such later date as may be decided by the Ministerial Conference (WT/L/1024). Despite indications 
that a number of Members are  actively pursuing their respective domestic procedures in order to 
accept the Protocol, not all Members concerned are expected to complete their respective domestic 
procedures by this deadline. The Council for TRIPS therefore submits the  attached proposal  to the 
General Council for a decision to extend the period for acceptances of  the Protocol. A draft of such 
a proposal for consideration by the Council is contained in Annex 2 of this document.  
3  MAKING THE SYSTEM WO RK 
14.  TRIPS Council Chairs have repeatedly r eferred delegations to the Council 's 2016 report on the 
annual review of the System (IP/C/76), as well as to the  WTO Secretariat 's 2016 annual report on 
its technical cooperation activities (IP/C/W/618) which provide useful information resources for 
future  considerations to make the System work in practice and, in particular, to prepare for the 
annual review of the System.11 
15.  Echoing the former TRIPS Council Chair 's note of the importance "to look into how to make this 
new procurement tool work effectively so  that it delivers concrete results in practice ",12 Members 
have called for awareness raising and capacity building for potential users of the System, targeting, 
 
11 See minutes of the TRIPS Council meetings of 30 January 2017 (document IP/C/M/84, para.9); 13 June 
2017 (document IP/C/M/86, para.38); 19 -20 October 2017 (documen t IP/C/M/87, para.21); 5 -6 June 2018 
(document IP/C/M/89, para.59); 8 -9 November 2018 (IP/C/M/901, para. 20); and 6 June 2019 (IP/C/M/92, 
para.93).  
12 See minutes of the TRIPS Council meeting of 30 January 2017 (document IP/C/M/84, para.9).  IP/C/84  
 
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  in particular, procurement officers in charge of buying medicines and representatives from IP of fices, 
as well as the provision of legislative assistance to countries that were considering implementing the 
System in domestic law.  
16.  In line with these deliberations of the Council for TRIPS following the entry into force of the 
amended Agreement in Janua ry 2017, the Secretariat has continued to provide technical assistance, 
in cooperation with multilateral partners, relating to the effective use of the System.13  
17.  Jointly with WHO and WIPO, the Secretariat organized a Regional Workshop on Public Health, 
Intellectual Property and Trade in Kuwait from 18 to 21 November 2018. It also organized, in close 
collaboration with WHO and WIPO, a subregional Workshop for UEMOA Members in Dakar, Senegal, 
from 2 to 4 July 2019 which brought together representatives from t rade and health ministries, IP 
offices and procurement agencies to discuss issues related to public health, intellectual property and 
procurement of medicines. Noting the positive evaluation of these and an earlier such activity held 
in Brazil for Latin Am erican countries in November 2017, the WTO Secretariat is exploring the 
possibility of convening similar workshops in other regions in response to continuing demand on the 
part of Members.  
18.  These capacity building activities complement the module dedicated to the System at the Trade 
and Health Workshop that the WTO organizes annually in Geneva. They are based on the 2013 WHO -
WIPO -WTO study on "Promoting Access to Medical Technologies and Innovation – Intersections 
Between Public Health, Intellectual Property  and Trade " which sets out explanatory background 
material on the implementation and use of the System.14 Updated background information is 
available on the WTO 's webpage dedicated to public health.15 Focused technical assistance materials 
have also been dev eloped to enable interested Members effectively to assess the operational context 
of the System and to support their effective use of it.  
_______________  
 
 
13 See 2018 WTO S ecretariat Report on Technical Cooperation in the TRIPS Area (document IP/C/W/645); 
the news item reporting on the Annual Workshop on Trade and Public Health organized by the WTO in 2018 
(https://www.wto.org/english/news_e/news18_e/tra_15oct18_e.htm ) and the Regional Workshop on Trade and 
Public Health With a Special Focus on Compulsory Licences for Export of Medicines for Countries from the Latin 
American Region held in Brazil from 21 -23 November 2017 (see document IP/C/W/645, para. 13).  
14 See pages 177 to 180 and Annex II of the study, available at the three organizations' respective 
websites: https://www.wto.org/english/res_e/publications_e/who -wipo-wto_2013_e.htm  
http://www.wipo.int/edocs/pubdocs/en/global_challenges/628/wipo_pub_628.pdf   
http://www.who.int/phi/promoting_access_medical_innovation/en/ .  
15 https://www.wto.org/english/tratop _e/trips_e/pharmpatent_e.htm .  IP/C/84  
 
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  ANNEX 1  
 
 [EXCERPT FROM THE M INUTES OF THE COUNCI L'S MEETING OF 17 -18 OCTOBER 2019 TO 
BE CIRCULATED AS IP/C/M /93] 
6  ANNUAL REVIEW OF THE  SPECIAL COMPULSORY LICENSING SYSTEM (PA RAGRAPH 7 
OF THE ANNEX TO THE AMENDED TRIPS AGREEM ENT AND PARAGRAPH 8 OF THE 
DECISION ON THE IMPL EMENTATION OF PARAGR APH 6 OF THE DOHA DE CLARATION ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH)  
1.  The Chair  recalled that, in the past, the review had been conducted pursuant to paragraph 6 of 
the 2003 Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health. Since the entry into force of the Protocol Amendi ng the TRIPS 
Agreement on 23 January 2017, the review also responded to the requirements that had now been 
incorporated into the amended TRIPS Agreement.   
2.  Paragraph 7 of the Annex to the amended TRIPS Agreement and paragraph  8 of the 2003 Waiver 
Decision r equired the Council to review the functioning of the System annually, with a view to 
ensuring its effective operation. They also required the Council to report annually on the System's 
operation to the General Council. In the case of the Waiver Decision, t his review was also deemed 
to fulfil the requirements of Article IX:4 of the WTO Agreement.  
3.  The Chair  update d Members on the status of acceptances of the TRIPS Protocol. The current 
period for accepting it  ran until 31 December 2019. The amended TRIPS Agre ement was thus binding 
for 128 WTO Members. In other words, 36 Members were yet to accept the Protocol Amending the 
TRIPS Agreement. He encourage d those Members to complete their domestic procedures as soon as 
possible.  
4.  When the TRIPS Amendment had entered  into force in January 2017, Members had noted that it 
would be useful to consider how to make this new procurement tool work effectively in practice.  He 
therefore encourage d Members  to engage in a constructive discussion which could also build on 
earlier reviews. As previous Chairs and he himself  had indicated on past occasions, Members might  
find two documents particularly helpful to facilitate their considerations. The first document was the 
Council's Annual Review of 2016  (circulated in document IP/C/76 ); and the second document was 
the Secretariat's 2016 Report on Technical Cooperation Activities  (circulated in  document 
IP/C/W/618 ). Annex  II of that report summarize d key issues that delegations might wish to consider 
to support the practical use of the System.  
5.  The representatives of India, Brazil , South Africa , Canada , the United States of America , Japan , 
Zimbabwe  and Barbados  took the floor . 
6.  The Council took note  of the statements made.  
7.  The Chair  turned  to the Council's report to the General Council. A draft report ha d been prepared 
by the Secretariat  (circulated in document JOB/IP/34) . It was modelled on previous years' reports 
and contain ed factual information on the implementation and use of the Syste m. Under the section 
on the Amendment to the TRIPS Agreement, it also include d a list of Members who were yet to 
accept the Protocol Amending the TRIPS Agreement. As with past reports, an extract from the 
Council's minutes on this agenda item w ould be atta ched to the report in Annex 1.  
8.  The Council also ha d to decide whether to extend the period for acceptance of the Protocol which 
currently r an until the end of 2019. Since there were 36 Members that ha d yet to accept the Protocol, 
the Chair  suggest ed that the Council once again extend the period for acceptance for another two 
years – until 31 December 2021. A draft decision for the General Council was included in Annex 2 
of the Draft Report.  
9.  The Council agreed  to adopt the draft report and to attach the record of the discussion to it, and 
to submit, for the General Council’s adoption, a decision to extend until 31 December 2021 the 
period for the acceptance by Members of the Protocol Amending the TRIPS Agreement.  
 
_______________  
 
  IP/C/84 
 
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  ANNEX 2  
  
  
  WT/L/..  
 
 
(19-0000)  Page: ../..  
    
AMENDMENT OF THE TRI PS AGREEMENT – SEVEN TH EXTENSION OF THE PERIOD FOR 
THE ACCEPTANCE BY ME MBERS OF THE PROTOCO L AMENDING  
THE TRIPS AGREEMENT  
DRAFT DECISION OF [D ATE] 
 The General  Council,  
 
 Conducting  the functions of the Ministerial  Conference in the interval between meetings  
pursuant to paragraph  2 of Article  IV of the Marrakesh Agreement establishing the World Trade 
Organization (the  "WTO Agreement "); 
 
 Having regard to paragraph  2 of the Decision o f the General  Council of 6  December  2005 on 
the Amendment of the TRIPS  Agreement (the  "TRIPS  Amendment  Decision ") and paragraph  3 of the 
Protocol Amending the TRIPS  Agreement (the  "Protocol ")1, which provide that the Protocol shall be 
open for acceptance b y Members until 1  December  2007 or such later date as may be decided by 
the Ministerial  Conference;  
 
 Recalling that the General Council, by its decision of 30  November  2017 
(the "2017 Extension Decision ")2, extended the period for acceptances of the Proto col by Members 
for the  sixth time until 31  December  2019 or such later date as may be decided by 
the Ministerial  Conference;  
 
 Recalling also that, pursuant to paragraph  3 of the TRIPS  Amendment  Decision and 
paragraph  4 of the Protocol, the Protocol took e ffect and entered into force on 23  January  2017 upon 
acceptance by two thirds of Members who had accepted it on or before that date in  accordance with 
the provisions of paragraph  3 of Article  X of the WTO  Agreement;  
 
 Noting that the Protocol takes effect for each other Member upon acceptance by it pursuant 
to paragraph 3 of Article X of the WTO Agreement;  
 
 Noting also  that a number of Members are yet to accept the Protocol and that this is taking 
them longer than initially foreseen;  
 
 Having considered the proposal to further extend the period for acceptances of the  Protocol 
submitted by the Council for TRIPS (IP/C/ 83); 
 
 Decides  as follows:  
 The period for acceptances by Members of the Protocol Amending the TRIPS Agreement 
referred to in paragraph  2 of the TRIPS  Amendment  Decision and paragraph  3 of the Protocol, 
and extended by the 2017  Extension  Decision, shall be further extended until 31  December  2021 
or such later date as may be decided by the Ministerial  Conference.  
 
_______________  
 
1 WT/L/641.  
2 WT/L/1024.  
IP/C/84  
 
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  APPENDIX 1  
[EXCERPT FROM THE AD DENDUM TO THE MINUTE S, CONTAINING THE ST ATEMENTS MADE 
DURING THE COUNCIL 'S MEETING HELD ON 17 -18 OCTOBER 2019, TO  BE CIRCULATED AS 
IP/C/M/93/ADD.1]  
AGENDA ITEM 6: ANNUA L REVIEW OF THE SPEC IAL COMPULSORY LICEN SING SYSTEM 
(PARAGRAPH 7 OF THE ANNEX TO THE AMENDED  TRIPS AGREEMENT AND  PARAGRAPH 8 
OF THE DECISION ON T HE IMPLEMENTATION OF  PARAGRAPH 6 OF THE DOHA 
DECLARATION ON THE T RIPS AGREEMENT AND P UBLIC HEALTH)  
6.1  India  
1.  India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public 
Health, the Paragraph 6 System as established under the 2003 Waiver Decision and the Protocol 
Amending the TRIPS Agreement. India is one of the first few countries tha t notified its acceptance 
of the Protocol in March 2007.  
2.  India has always been of the view that the Doha Declaration on TRIPS and Public Health 
constituted a major landmark in the history of the WTO because it recognized the primacy of public 
health needs  and the preparedness of the Organization to address the problems in access to 
medicines faced by the poor in developing countries. The 2003 Waiver Decision was expected to 
address the public health problems faced by Members with insufficient or no manufac turing 
capacities in the pharmaceutical sector. It may have sounded prophetic at that time when India 
voiced certain apprehensions in the GC meeting of August 2003  by stating:  "the results accruing 
from this mechanism should not be negated by the creation of cumbersome systems that would lead 
to huge delays in getting medicines across at reasonable cost to those that needed them or 
discourage Members from using the system for the benefit of the people. In order to make this 
system successful, a sincere coll ective effort is required on the part of all Members and the entire 
pharmaceutical industry". Regrettably, we have been proven right. The export of HIV/AIDS 
medicines by the Canadian pharmaceutical company Apotex to Rwanda in September 2008 has been 
the first and only use of the system so far.  
3.  The United Nations Secretary -General’s High-Level Panel on Access to Medicines, in its report 
released in September 2016, also recognized that the Para graph  6 System is complex and 
cumbersome.  
4.  My delegation urges Mem bers to constructively engage on improving the Paragraph 6 System 
for making it more workable and effective, so that it can benefit Members with insufficient or no 
manufacturing capacities in the pharmaceutical sector.  
6.2  Brazil  
5.  Brazil thanks the WTO Secreta riat for preparing the draft report. Legislation to implement the  
amendment to the TRIPS Agreement  contained  in Article 31 bis has been in force in Brazil since 21 
February 2018.  
6.  We mostly welcome capacity building activities and assistance material aimin g at the promotion 
of access to medical technologies and innovation for the implementation and use of the System, in 
order to enable interested Members effectively to assess it.  
7.  A basic tenet of the patent system is that legislation should provide incentiv es that lead to new 
discoveries and inventions, while ensuring that those incentives are not overly restrictive and do not 
create barriers to innovation and dissemination of knowledge.  
8.  Brazil believes that all Member have the obligation to pursue a balanc e between the interests of 
the IP right holders and those of society as a whole. Preserving such balance is the best way to 
safeguard the legitimate interests of all stakeholders of the patent system. For instance, the 
regulatory review exception, also kno wn as the Bolar exception, plays an important role in providing IP/C/84 
 
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  the realization of that balance, especially by ensuring that the market power granted by a patent 
does not create anti -competitive externalities beyond the term of protection of 20 years.  
9.  This is also true regarding compulsory license for patents. Brazil is of the view that this is a very 
important exception to restore the balance in the special cases when its use is required, such as, 
but not limited to, emergency health situations or the anti competitive use of patents.  
10.  We find that this particular exception should be used within the rules provided in the 
TRIPS  Agreement and the Doha Declaration on the TRIPS Agreement and Public Health in the context 
of finding a balance between the incentives to innovation and the enhancement of access to the 
technology embodied in the patent.  
11.  Brazil thus thanks the Secretariat and supports the proposal to the General Council for a decision 
to extend the period for acceptances of the Protocol.  
6.3  South Africa  
12.  We w ould like to thank the Secretariat for this update. The Protocol Amending the 
TRIPS  Agreement entered into force on 23 January 2017, since at that time two thirds of 
WTO Members had accepted it. Given the importance of the amendments effected by the Protoc ol 
we call on Members who have not yet accepted the Protocol to do so as soon as possible.  
13.  The Protocol is currently open for acceptance by these Members until 31 December 2019. In 
order allow Members who have not yet deposited their instruments of accept ance, South Africa 
would be in favour of a further extension of the 2017 Extension Decision until 31 December 2021 or 
a date that may be stipulated by the next Ministerial Conference as suggested in the proposed draft 
decision contained in Annex 2 of docum ent JOB/IP/34. South Africa would be in favour of supporting 
such a draft decision.  
6.4  Canada  
14.  Canada notes the importance of access to medicines in promoting global health and prosperity. 
For instance, Canada has supported international financing organizatio ns such as the Global Fund to 
Fight AIDS, Tuberculosis and Malaria; Gavi, the Vaccine Alliance; and the Global Financing Facility, 
which strengthen health systems and undertake targeted programming to increase access to 
medicines and vaccines.  
15.  Canada's Ac cess to Medicines Regime (or CAMR), which implements paragraph 6 of the 
Doha Declaration on the TRIPS Agreement and Public Health, is another measure used in Canada to 
promote access to medicines. In 2015, Canada amended the list of medications covered by CAMR 
to add three new antiretroviral drugs. Canada notified this amendment to the TRIPS Council in 
June 2016.  
16.  Canada also takes note of the 2017 entry into force of the Protocol amending the 
TRIPS  Agreement, and as the only country to have exported medicin e pursuant to the temporary 
waiver, as was noted by the delegation of India, Canada would be pleased to share its experiences 
and lessons learned in implementing our own system with any Members who wish to learn more.  
6.5  United States of America  
17.  The United St ates welcome the entry into force of the Protocol Amending the TRIPS  Agreement.  
18.  We welcome the Secretariat's draft Report and its work throughout the year to facilitate and 
encourage all Members to notify their acceptance of the Protocol.  
19.  We also congratu late the Members that have accepted the Protocol since the entry into force of 
the amended TRIPS Agreement.  
20.  While the entry into force of the amended TRIPS Agreement represented an important step in 
promoting our shared goal of facilitating access to medic ines, it is only one piece of the puzzle.  IP/C/84  
 
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  21.  We encourage Members to continue to focus efforts to address other salient barriers to access 
while also recognizing the important role that intellectual property and international trade 
liberalization play in ince ntivizing drug development and expanding access to medicines around the 
world.  
22.  For example, the World Hea lth Organization has identified numerous considerations, including 
pricing and procurement policies, taxes, mark -ups and tariffs, and other national po licies that 
ultimately result in higher costs for consumers and for health systems.  
23.  While we remain disappointed that such a large number of  Members have yet to notify their 
acceptance of the Protocol, we support the proposal to extend the period of acceptance for 
two-years.  
6.6  Japan  
24.  This delegation would like to express our gratitude to the Secretariat for preparing a draft report 
as the basis f or the  review of the Special Compulsory Licensing System. We welcome this work, 
hoping that it will encourage all remaining Members to notify their acceptance of the Protocol.  
25.  This delegation would like to reiterate the importance of access to medicine s, which needs to 
be discussed in a broader context, taking into account not only the Special Compulsory Licensing 
System but also various other relevant measures and factors such as procurement and tariffs. Japan 
supports the Paragraph 6 System as establis hed under the 2003 waiver decision and the 2005 
Protocol Amending the TRIPS Agreement. The very objective of the System is to support WTO 
Members in obtaining greater access to medicines, specifically Members that have either insufficient 
or no pharmaceuti cal manufacturing capacity. Compulsory licenses are, whether granted under the 
System or not, just one of the potential means that can be utilized for this objective under an 
exceptional circumstance . Therefore, the System should not be considered as the o nly solution, but 
rather as just an option we could consider.  
26.  Regarding the extension of the period for acceptance of the Protocol, this delegation supports 
the proposed two-year extension.  
6.7  Zimbabwe  
27.  The delegation of Zimbabwe reiterates previous submission s on this subject matter, in reference 
of the goals of the Protocol amending the TRIPS Agreement, we would like to lend out our 
unconditional support for the extension for Members that have not yet joined the Protocol to accept 
it.  
6.8  Barbados  
28.  Barbados would  like to indicate that the  domestic acceptance  process is in and advanced stage . 
We will fully support the extension of  the period for  acceptance until 2021.  
6.9  India  
29.  India fully supports the two -year extension of the period for acceptance.  
 
__________